OTTAWA, Dec. 20, 2018 /CNW/ -
Issue: Health Canada has released the results of its testing of sartan drugs in Canada. Health Canada tested samples of certain sartan drugs (valsartan, candesartan, irbesartan, losartan, and olmesartan), which represent numerous products, as part of its ongoing collaborative work to address impurities found in some sartan drugs in Canada and internationally.
Sartans, also known as angiotensin II receptor blockers (ARBs), are a class of drugs used as a treatment for patients with high blood pressure to help prevent heart attacks and stroke. They are also used in patients who have had heart failure or a recent heart attack.
Several valsartan products have been recalled in Canada since this summer, after the impurities N?nitrosodiethylamine (NDEA) and N-nitrosodimethylamine (NDMA) were found in the active pharmaceutical ingredient. Both NDEA and NDMA are classified as probable human carcinogens, which means that long-term exposure could increase the risk of cancer. Health Canada has previously communicated cancer risk estimates for NDMA based on the levels detected in certain recalled valsartan products.
Health Canada tested 48 samples representing 43 different products and did not identify any new safety concerns. Of the 48 samples, six valsartan samples representing four products were found to contain levels of impurities that were, on average, higher than what is considered to be reasonably safe. All four of the products have already been recalled from the Canadian market.
Health Canada's assessment is ongoing
While Health Canada's assessment initially focused on valsartan, the Department expanded its scope in consideration that NDMA and NDEA impurities could potentially be present in certain other sartans. The five sartan drugs Health Canada is focused on (valsartan, candesartan, irbesartan, losartan, and olmesartan) all share a similar chemical structure. Based on information to date, sartans that do not have this chemical structure are not thought to be at risk for the formation of NDMA, NDEA or other similar impurities.
Health Canada continues to hold manufacturers responsible for the safety and effectiveness of drugs sold on the Canadian market.
The Department has requested and assessed information from companies and—based on its own analysis and information shared by international regulatory partners—believes that the impurities found in certain sartans may be linked to certain manufacturing processes and practices.
Health Canada has asked companies marketing the five sartans in Canada to test their products for the NDMA and NDEA impurities. The testing applies to product currently available in Canada and to any new inventory before its release. To support this initiative, Health Canada is also publishing a laboratory test method to provide an option for regulators and industry to detect NDMA and NDEA impurities. Health Canada will continue to assess new developments to determine whether additional testing is necessary.
Health Canada continues to work closely with international regulatory partners, including the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), to investigate probable causes for the presence of these impurities, to align actions where appropriate, and to identify measures to prevent this situation from happening again.
Health Canada's actions to date
Health Canada actions taken to date include:
As with previous communications regarding NDEA and NDMA, Health Canada is advising that there is no immediate risk to patients taking these medications, since the risk of cancer is with long-term exposure to the impurities that exceed safe levels. Patients should not stop taking their medication unless on the advice of their healthcare provider.
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Issue: Health Canada has released the results of its testing of sartan drugs in Canada. Health Canada tested samples of certain sartan drugs (valsartan, candesartan, irbesartan, losartan, and olmesartan), which represent numerous products, as part of its ongoing collaborative work to address impurities found in some sartan drugs in Canada and internationally.
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Sartans, also known as angiotensin II receptor blockers (ARBs), are a class of drugs used as a treatment for patients with high blood pressure to help prevent heart attacks and stroke. They are also used in patients who have had heart failure or a recent heart attack.
Several valsartan products have been recalled in Canada since this summer, after the impurities N?nitrosodiethylamine (NDEA) and N-nitrosodimethylamine (NDMA) were found in the active pharmaceutical ingredient. Both NDEA and NDMA are classified as probable human carcinogens, which means that long-term exposure could increase the risk of cancer. Health Canada has previously communicated cancer risk estimates for NDMA based on the levels detected in certain recalled valsartan products.
Health Canada tested 48 samples representing 43 different products and did not identify any new safety concerns. Of the 48 samples, six valsartan samples representing four products were found to contain levels of impurities that were, on average, higher than what is considered to be reasonably safe. All four of the products have already been recalled from the Canadian market.
Health Canada's assessment is ongoing
While Health Canada's assessment initially focused on valsartan, the Department expanded its scope in consideration that NDMA and NDEA impurities could potentially be present in certain other sartans. The five sartan drugs Health Canada is focused on (valsartan, candesartan, irbesartan, losartan, and olmesartan) all share a similar chemical structure. Based on information to date, sartans that do not have this chemical structure are not thought to be at risk for the formation of NDMA, NDEA or other similar impurities.
Health Canada continues to hold manufacturers responsible for the safety and effectiveness of drugs sold on the Canadian market.
The Department has requested and assessed information from companies and—based on its own analysis and information shared by international regulatory partners—believes that the impurities found in certain sartans may be linked to certain manufacturing processes and practices.
Health Canada has asked companies marketing the five sartans in Canada to test their products for the NDMA and NDEA impurities. The testing applies to product currently available in Canada and to any new inventory before its release. To support this initiative, Health Canada is also publishing a laboratory test method to provide an option for regulators and industry to detect NDMA and NDEA impurities. Health Canada will continue to assess new developments to determine whether additional testing is necessary.
Health Canada continues to work closely with international regulatory partners, including the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), to investigate probable causes for the presence of these impurities, to align actions where appropriate, and to identify measures to prevent this situation from happening again.
Health Canada's actions to date
Health Canada actions taken to date include:
- Requesting that companies recall products found to contain NDMA and NDEA that exceeded acceptable levels, and monitoring the effectiveness of those recalls;
- Requesting and assessing information from companies on the manufacturing processes for the five sartan drugs to identify potential causes of the impurities and mitigation measures;
- Stopping the import of active pharmaceutical ingredients—and requiring the testing of inventory that had already been imported—from the Chuannan site of Zhejiang Huahai Pharmaceuticals in China, because of general concerns with their manufacturing practices and procedures;
- Testing samples of the five sartans for NDMA and NDEA impurities; and
- Requesting companies to test the five sartans for the NDMA and NDEA impurities.
As with previous communications regarding NDEA and NDMA, Health Canada is advising that there is no immediate risk to patients taking these medications, since the risk of cancer is with long-term exposure to the impurities that exceed safe levels. Patients should not stop taking their medication unless on the advice of their healthcare provider.
Related links
- Impurities found in certain angiotensin II receptor blocker (ARB) products, also known as sartans
- Health Canada information update (2018-11-29): Mylan-Valsartan voluntarily recalled as a precaution due to an impurity
- Health Canada information update (2018-10-02): Health Canada finds Zhejiang Huahai Pharmaceuticals site non-compliant with requirements for the manufacture of drug ingredients
- Health Canada information update (2018-09-13): Health Canada advises of a second impurity linked to recalled valsartan drugs
- Health Canada information update (2018-09-10): Health Canada updates Canadians on estimates of health risks for recalled valsartan drugs containing NDMA
- Health Canada information update (2018-08-18): Teva Canada expands recall of valsartan drugs to include additional lots, as a precaution
- Health Canada advisory (2018-07-09): Several drugs containing valsartan being recalled due to contamination with a potential carcinogen
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SOURCE Health Canada
